(20 days)
The Synthes 4.5 mm and 6.5 mm Headless Compression Screws are indicated for fracture fixation, reconstruction, osteotomy, and arthrodesis of various bones and bone fragments including joint fusions (arthrodeses) in the foot and fixation of intra-articular fractures of the humerus, femur and tibia.
Synthes 4,5 mm and 6,5 mm Headless Compression Screws are cannulated and are self-drilling/self tapping, feature a StarDrive recess, and have a threaded head which can be countersunk into the bone. They are available in stainless steel and titanium alloy, in a variety of lengths.
The provided text is a 510(k) summary and FDA clearance letter for a medical device (Synthes 4.5 mm and 6.5 mm Headless Compression Screws). This type of document is a regulatory submission for a medical device and does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or performance testing documentation for software/AI devices.
The 510(k) process demonstrates substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a dedicated study.
Therefore,Based on the provided text, I cannot extract any information regarding:
- Acceptance criteria and reported device performance table: The document does not specify performance acceptance criteria or report performance metrics in this format.
- Sample size and data provenance for a test set: No test set is described.
- Number and qualifications of experts for ground truth: No such experts are mentioned.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
This document focuses on the description of the device, its intended use, classification, and its substantial equivalence to predicate devices to obtain FDA clearance, not on a detailed study proving its performance against acceptance criteria.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.